Skin Test Study of BM32
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, by Skin Testing|
- wheal size of immediate type skin reactions to the mix of BM32 proteins wheal size of immediate type skin reactions to the wheal size of immediate type skin reaction to the mix of BM32 proteins [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]For skin prick testing a drop of the test solution will be placed on the subjects´ skin at a distance of at least 2 cm between individual application points. The skin will be pricked with sterile prick lancets. Reactions will be recorded after 20 minutes by measuring the diameters of the wheal. Wheals of more than 3 mm diameter will be regarded as positive reactions.
|Study Start Date:||May 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
BM32 is a hypoallergenic grass pollen allergy vaccine which consists of an aluminum hydroxide-adsorbed equimolar mix of four active ingredients, BM321, BM322, BM325 and BM326. The four active ingredients are purified recombinant proteins containing non-allergenic peptides from the four major timothy grass pollen allergens, Phl p 1 (BM321), Phl p 2 (BM322), Phl p 5 (BM325) and Phl p 6 (BM326) which are fused to the PreS domain of hepatitis B virus, a protein used in childhood vaccines. BM32 holds promise not to induce IgE mediated immediate type (e.g. anaphylactic reactions) or T-cell mediated late phase side effects during immunotherapy.
The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins due to their low/absent IgE- and T cell-reactivity exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients (n=60). This study will therefore provide important information for immunotherapy studies based on BM32.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350635
|Vienna, Austria, 1090|